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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number P101520
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced recurrence, mesh migration, pain and infection. Post-operative patient treatment included excision surgery.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of recurrent bilateral inguinal hernias. It was reported that after implant, the patient experienced recurrence, mesh migration, pain and infection. Post -operative patient treatment included excision surgery. The product had been used with 0112970 bard mesh perfix plug (right), lot# huyg0854 and 0112970 bard mesh perfix plug (left), lot# huwl1317.
 
Manufacturer Narrative
Concomitant medical products: 0112970 bard mesh perfix plug (right) (lot# huyg0854) , 0112970 bard mesh perfix plug (left) (lot# huwl1317). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire CT GU11 1EJ
GB GU11 1EJ
MDR Report Key8881874
MDR Text Key153941354
Report Number1219930-2019-04681
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
2019-07-24
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/18/2016
Device Model NumberP101520
Device Catalogue NumberP101520
Device Lot Number13B1309X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/11/2019 Patient Sequence Number: 1
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